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Istodax Approval History

  • FDA approved: Yes (First approved November 5th, 2009)
  • Brand name: Istodax
  • Generic name: romidepsin
  • Dosage form: for Injection
  • Company: Gloucester Pharmaceuticals
  • Treatment for: Cutaneous T-cell Lymphoma

Istodax (romidepsin) a histone deacetylase (HDAC) inhibitor indicated the treatment of cutaneous T-cell lymphoma and peripheral T-cell lymphoma.

Development History and FDA Approval Process for Istodax

Jun 17, 2011Approval FDA Grants Accelerated Approval of Istodax As Treatment for Patients with Peripheral T-Cell Lymphoma Who Have Received at Least One Prior Therapy
Nov  6, 2009Approval FDA Approves Gloucester Pharmaceuticals' Istodax for Patients with Cutaneous T-cell Lymphoma
Sep  2, 2009FDA Advisory Committee Recommends Gloucester Pharmaceuticals' Romidepsin for Approval for Cutaneous T-cell Lymphoma
Aug 18, 2009Gloucester Pharmaceuticals Announces FDA Advisory Committee Meeting to Discuss Romidepsin New Drug Application

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